WASHINGTON – The Environmental Protection Agency on Wednesday proposed banning pesticide testing on pregnant women and children. The move followed criticism that the government's reliance on human pesticide tests (search) has irresponsibly endangered vulnerable people.
"We want to send a clear signal to the public that unethical research should never be conducted and will not be accepted by EPA," Susan B. Hazen, principal deputy assistant administrator in EPA's Office of Prevention, Pesticides, and Toxic Substances, said in a statement. "We should consider human data only if that information has been developed with the foremost goal of providing protections for research participants."
Critics, however, said the proposed regulation, the agency's first specifically aimed at human pesticide testing, contains too many loopholes. Among them: not banning the use of data from unintentional or everyday exposure of pregnant women and children to pesticides.
"It has so many exceptions, it's not an unvarnished advance," said Jeff Ruch, executive director of Public Employees for Environmental Responsibility. "There are far more safeguards for similar studies for drugs and medicines to help people."
An EPA spokeswoman declined additional comment in advance of a media briefing to be held later in the day.
The rule would take effect after a 90-day public comment period. It categorically prohibits pesticide testing studies, conducted with or without federal government sponsorship, that involve intentionally dosing pregnant women or children. It requires people conducting other human testing to submit protocols to EPA for review.
It also establishes an independent Human Studies Review Board to review proposals for human dosing studies.
Earlier this year, controversy forced EPA to cancel a study that would have paid families in a low-income Florida neighborhood to allow their children to be tested for household exposure to pesticides. In response, Congress included language in a spending bill restricting testing on humans.
Ruch said it appears that the Florida study would have been able to go forward under the proposed new rule.
An industry group praised the proposal.
"We believe it has the potential to establish ethical and scientific safeguards and uniform standards to protect research subjects and improve the risk assessment process," Jay Vroom, president of CropLife America (search), which represents pesticide developers and manufacturers, said in a statement.
EPA stopped accepting industry data from experiments on humans near the end of the Clinton administration. But the U.S. Court of Appeals for the District of Columbia ruled in 2003 in a suit brought by the pesticide industry that the EPA cannot refuse to consider data from manufacturer-sponsored human exposure tests until it developed regulations on the issue.
The agency now uses human testing studies after evaluating them on a case-by-case basis.